FAQs

  • Yes! We provide audits for:

    • Pre-inspection review of your site and processes

    • Contractor audits

    • Full GDP audits of your site and processes

    • Third party site audits

    • Supplier audits

    Contact us for more information.

  • Yes! We can help you design and implement effective SOPs and provide templates and help you design your SOPs from the ground up.

  • Yes! If your business is looking to obtain a WDA and you need any advice or support in this respect, we can help.

  • Everyone working in the pharmaceutical wholesale environment needs to be aware of GDP to a lesser or greater extent, depending on their role.

    We provide bespoke training to suit your business for anyone from operational staff through to senior management.

    We also offer extensive and bespoke RP training and training on a range of more specific topics such as Quality Risk Management, Root Cause Analysis or Effective Transport Provision. Please Contact us to discuss your needs.

  • Yes! We offer contract RP/RPi services. A contract RP/RPi is generally not based onsite full-time.

    Peter and Claire are highly experienced and can act effectively as an RP/RPi in any size or type of WDA holder currently operating in the UK. Please Contact us for an informal discussion.

  • The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.

    The agency is responsible for: ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy; ensuring that the supply chain for medicines, medical devices and blood components is safe and secure; promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines; helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use; supporting innovation and research and development that’s beneficial to public health; and influencing UK, EU and international regulatory frameworks so that they’re risk-proportionate and effective at protecting public health.

  • Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

  • A QMS is a Quality Management System. In GDP terms, it is the combination of your people, process, facilities, equipment and IT, not just a set of SOPs.

    Implementing and maintaining an effective QMS keeps you on the right side of compliance.

    MHRA Inspectors will always be mindful of a well implemented QMS.

    We offer a QMS design and Audit service. if you need more information or would like to discuss this service please contact us.

  • As a WDA holder you are required to carry out qualification checks on your suppliers and customers.

    This is to ensure that they are operating safely and in accordance with regulations and to maintain the legal supply chain.

    This involves you carrying out your due-diligence checks.

    There are main three steps to effectively qualifying suppliers and customers:

    • Authorised supplier/customer holds a manufacturing or wholesale dealers licence or is otherwise entitled to receive medicinal products

    • Authorised supplier/customer complies with GDP (GDP certificate available)

    • Due diligence checks (including evaluation of on-site audits, where applicable)

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